A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05508789

Collaborator

(none)

800

Enrollment

148

Locations

Arms

Anticipated Duration (Months)

5.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders	Drug: Donanemab Drug: Placebo	Phase 3

Detailed Description

TRAILBLAZER-ALZ 5 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain tau pathology.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

Anticipated Study Start Date :

Oct 10, 2022

Anticipated Primary Completion Date :

Jul 16, 2025

Anticipated Study Completion Date :

Sep 10, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Donanemab Participants will receive donanemab intravenously (IV)	Drug: Donanemab Administered IV Other Names: (LY3002813)
Placebo Comparator: Placebo Participants will receive placebo IV	Drug: Placebo Administered IV

Arm

Intervention/Treatment

Experimental: Donanemab

Participants will receive donanemab intravenously (IV)

Drug: Donanemab

Administered IV

Other Names:

(LY3002813)

Placebo Comparator: Placebo

Participants will receive placebo IV

Drug: Placebo

Administered IV

Outcome Measures

Primary Outcome Measures

Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) [Baseline, Week 76]
Change from Baseline on the iADRS in at least one of 'the low-medium tau pathology population or the overall population'.

Secondary Outcome Measures

Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) [Baseline, Week 76]
Change from Baseline CDR-SB in at least one of 'the low-medium tau pathology population or the overall population'.
Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale ADAS-Cog13 Score [Baseline, Week 76]
Change from Baseline on the ADAS-Cog13 Score in at least one of 'the low-medium tau pathology population or the overall population'.
Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living ADCS-iADL Score [Baseline, Week 76]
Change from Baseline ADCS-iADL Score in at least one of 'the low-medium tau pathology population or the overall population'.
Change from Baseline on the Mini Mental State Examination (MMSE) Score [Baseline, Week 76]
Change from Baseline on the MMSE Score in at least one of 'the low-medium tau pathology population or the overall population'.
Change from Baseline in Amyloid Plaque Deposition as by Florbetapir F18 Positron Emission Tomography (PET) Scan [Baseline, Week 76]
Pharmacokinetics (PK): Average Serum Concentration of Donanemab [Baseline to Week 76]
Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs) [Week 76]
Change from Baseline in Quality of Life in Alzheimer's Disease (QOL-AD) [Baseline, Week 76]
Change from baseline in the QoL-AD in at least one of 'the low-medium tau pathology population or the overall population'.
Change from Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite) [Baseline, Week 76]
Change from baseline in the RUD-Lite in at least one of 'the low-medium tau pathology population or the overall population'.
Change from Baseline in Neuropsychiatric Inventory (NPI) [Baseline, Week 76]
Change from baseline in the NPI in at least one of 'the low-medium tau pathology population or the overall population'.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Gradual and progressive change in memory function reported by the participant or informant for ≥6 months
A MMSE score of 20 to 28 (inclusive) at Day 601 or 1.
Meet flortaucipir F18 scan (central read) criteria
Meet florbetapir F18 scan (central read) criteria
Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to the study or be available by telephone at designated times.
A second study partner may serve as backup. The study partner(s) is/are required to accompany the participant for signing consent. The study partner must be present on all days the cognitive and functional scales are administered.
If a participant has a second study partner, it is preferred that 1 study partner be primarily responsible for the CDR and the ADCS-ADL assessments.
Days requiring the following assessments and scales must have a study partner available by telephone if not accompanying participant for the following assessments
AEs and concomitant medications
CDR, and
ADCS-ADL
Stable concomitant symptomatic AD medications and other medications that may impact cognition for at least approximately 30 days prior to randomization.

Exclusion Criteria:

Has significant neurological disease affect the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of <24 months.
History of cancer within the last 5 years, except of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with low risk of recurrence or spread.
Contraindication to MRI or PET scans

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Brussel	Brussels	Bruxelles-Capitale, Région De	Belgium	1090
2	Cliniques universitaires Saint-Luc	Brussels	Bruxelles-	Belgium	1200
3	Jessa Ziekenhuis	Hasselt	Limburg	Belgium	3500
4	Clinical Chc Montlégia	Liege	Liège	Belgium	4000
5	UZ Gent	Gent	Oost-Vlaanderen	Belgium	9000
6	UZ Leuven	Leuven	Vlaams-Brabant	Belgium	3000
7	AZ Sint-Jan Brugge-Oostende AV	Brugge	West-Vlaanderen	Belgium	8000
8	AZ Groeninge Campus Kennedylaan	Kortrijk	West-Vlaanderen	Belgium	8500
9	Beijing Hospital	Beijing	Beijing	China	100005
10	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing	China	100020
11	Beijing Friendship Hospital Affiliate of Capital University	Beijing	Beijing	China	100050
12	Xuanwu Hospital Capital Medical University	Beijing	Beijing	China	100053
13	Beijing Tiantan Hospital Affiliated to Capital Medical University	Beijing	Beijing	China	100071
14	Beijing Anding Hospital - Affiliated Capital University of Medical Science	Beijing	Beijing	China	100088
15	Beijing Peking Union Medical College Hospital	Beijing	Beijing	China	100730
16	Chinese PLA General Hospital	Beijing	Beijing	China	100853
17	Peking University Sixth Hospital	Haidian District	Beijing	China	100191
18	The First Affiliated Hospital Chongqing Medical University	Chongqing	Chongqing	China	400016
19	Fujian Medical University Union Hospital-1 Bingfanglou	Fuzhou Fujian	Fujian	China	350001
20	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510120
21	Guangzhou First People's Hospital	Guangzhou	Guangdong	China	510180
22	Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China
23	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China
24	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150001
25	Tongji Hospital Tongji Medical,Science & Technology	Wuhan	Hubei	China	430030
26	Renmin Hospital of Wuhan University	Wuhan	Hubei	China	430060
27	Xiangya Hospital Central South University	Changsha	Hunan	China	410008
28	The Second Xiangya Hospital of Central South University	Changsha	Hunan	China	410011
29	Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210000
30	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China	210011
31	Nanjing Brain Hospital	Nanjing	Jiangsu	China	210029
32	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215004
33	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215006
34	Wuxi People's Hospital	Wuxi	Jiangsu	China	214023
35	The Affiliated Hospital of Xuzhou Medical College	Xuzhou	Jiangsu	China	221006
36	Xuzhou Central Hospital	Xuzhou	Jiangsu	China	221018
37	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu	China	212000
38	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China	330006
39	The First Hospital of Jilin University	Changchun	Jilin	China	100012
40	Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army	Xi'an	Shaanxi	China	710038
41	Xianyang Hospital of Yan'an University	Xianyang	Shaanxi	China	712000
42	Jinan Central Hospital	Jinan	Shandong	China	250013
43	Shanghai Mental Health Center	Shanghai	Shanghai	China	200030
44	Huashan Hospital Affiliated Fudan University	Shanghai	Shanghai	China	200040
45	Shanghai Tongji Hospital(CCBR site)	Shanghai	Shanghai	China	200065
46	Shanghai General Hospital	Shanghai	Shanghai	China	200080
47	Shanghai 6th people's hospital	Shanghai	Shanghai	China
48	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai	China
49	West China Hospital of Sichuan University	Cheng Du	Sichuan	China	610041
50	Sichuan Provincial People's Hospital	Chengdu	Sichuan	China	610072
51	Tianjin Huanhu Hospital	Tianjin	Tianjin	China	300050
52	Tianjin Medical University General Hospital	Tianjin	Tianjin	China	300052
53	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang	China	310003
54	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang	China	310014
55	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang	China	310016
56	The Second Affiliated hospital of Zhejiang University school of medicine	Hangzhou	Zhejiang	China	310052
57	The First Hospital of Hebei Medical University	Shijiazhuang		China	050031
58	A-Shine	Plzen	Plzeň-měst	Czechia	301 00
59	Neurologická Ambulance - Forbeli	Praha	Praha 6	Czechia	160 00
60	Clinline s.r.o.	Hostivice	Středočeský Kraj	Czechia	253 01
61	Neuroterapie KH s.r.o.	Kutná Hora	Středočeský Kraj	Czechia	284 01
62	Brain-Soul Therapy	Kladno		Czechia	272 01
63	Neuropsychiatrie s.r.o	Prague		Czechia	160 00
64	Vestra Clinics	Rychnov nad Kněžnou		Czechia	516 01
65	Centre Pour Personnes Agees	Colmar	Alsace	France	68000
66	CHU Strasbourg-Hautepierre	Strasbourg	Alsace	France	67098
67	Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone	Marseille	Bouches-du-Rhône	France	13385
68	Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand	Dijon	Bourgogne	France	21000
69	Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau	Tours	Centre	France	37044 Cede
70	Centre Hospitalier Universitaire Toulouse - Cité de la Santé	Toulouse	Haute-Garonne	France	31000
71	CHU Charles Nicolle	Rouen	Haute-Normandie	France	76031
72	Hopital Gui de Chauliac	Montpellier	Languedoc-Roussillon	France	34295
73	Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes	Saint-Herblain	Loire-Atlantique	France	44800
74	Centre Hospitalier Universitaire Régional de Nancy	Nancy	Meurthe-et-Moselle	France	54035
75	Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan	Toulouse	Midi-Pyrénées	France	31059
76	Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro	Lille	Nord-Pas-de-Calais	France	59037
77	Hospices Civils de Lyon - Hôpital Femme Mère Enfant	Bron	Rhône	France	69500
78	Hôpital des Charpennes - Hospices Civils de Lyon (HCL)	Villeurbanne	Rhône	France	69100
79	Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière	Paris		France	75010
80	Pitie Salpetriere University Hospital	Paris		France	75013
81	Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou	Rennes		France	35000
82	ISPG - Institut für Studien zur Psychischen Gesundheit	Mannheim	Baden-Württemberg	Germany	68165
83	Klinikum Rechts Der Isar Der Technischen Universität München	Munich	Bayern	Germany	81675
84	Klinische forschung Schwerin GmbH	Schwerin	Mecklenburg-Vorpommern	Germany	19055
85	Universitätsmedizin Göttingen - Georg-August-Universität	Göttingen	Niedersachsen	Germany	37075
86	Klinische Forschung Hannover-Mitte	Hannover	Niedersachsen	Germany	30159
87	Universitaetsklinikum Schleswig-Holstein Campus Kiel	Kiel	Schleswig-Holstein	Germany	24105
88	Klinikum Altenburger Land	Altenburg	Thüringen	Germany	04600
89	Charité Universitätsmedizin Berlin - Campus Berlin Buch	Berlin		Germany	13125
90	Klinische Forschung Hamburg	Hamburg		Germany	20253
91	Inha University Hospital	Incheon	Incheon-gwangyeoksi [Incheon]	Korea, Republic of	22332
92	Gachon University Gil Medical Center	Namdong-gu	Incheon-gwangyeoksi [Incheon]	Korea, Republic of	21565
93	Hanyang University Guri Hospital	Guri-si	Kyǒnggi-do	Korea, Republic of	11923
94	Seoul National University Bundang Hospital	Seongnam	Kyǒnggi-do	Korea, Republic of	13620
95	Seoul National University Bundang Hospital	Seongnam	Kyǒnggi-do	Korea, Republic of	13620
96	Ajou University Hospital	Suwon-si	Kyǒnggi-do	Korea, Republic of	16499
97	Korea University Anam Hospital	Seoul	Seoul-teukbyeolsi [Seoul]	Korea, Republic of	02841
98	Severance Hospital, Yonsei University Health System	Seoul	Seoul-teukbyeolsi [Seoul]	Korea, Republic of	03722
99	Hanyang University Seoul Hospital	Seoul	Seoul-teukbyeolsi [Seoul]	Korea, Republic of	04763
100	Konkuk University Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]	Korea, Republic of	05030
101	Asan Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]	Korea, Republic of	05505
102	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]	Korea, Republic of	06351
103	Ewha Womans University Mokdong Hospital	Seoul	Seoul-teukbyeolsi [Seoul]	Korea, Republic of
104	Seoul National University Hospital	Seoul	Seoul-teuk	Korea, Republic of
105	Brain Research Center Den Bosch B.V.	's-Hertogenbosch	Noord-Brabant	Netherlands	5223 LA
106	Brain Research Center	Amsterdam	Noord-Holland	Netherlands	1081 GN
107	Brain Research Center Zwolle	Zwolle	Overijssel	Netherlands	8025 AZ
108	Globe Badania Kliniczne	Klodzko	Dolnośląskie	Poland	57-300
109	Osrodek Badawczo - Naukowo - Dydaktyczny Chorob Otepiennych w Scinawie - Osrodek Alzheimerowski Sp. z o.o.	Scinawa	Dolnośląskie	Poland	59-330
110	Wroclawskie Centrum Alzheimerowskie	Wroclaw	Dolnośląskie	Poland	53-659
111	Centrum Medyczne NEUROMED	Bydgoszcz	Kujawsko-p	Poland	85-163
112	Private Practice - Dr. Urszula Chyrchel- Paszkiewicz	Lublin	Lubelskie	Poland	20-093
113	Clinirem	Warszawa	Mazowieckie	Poland	00-773
114	Centrum Medyczne NeuroProtect	Warszawa	Mazowieckie	Poland	01-684
115	Diamond Clinic	Krakow	Małopolskie	Poland	31-559
116	KLIMED Marek Klimkiewicz	Białystok	Podlaskie	Poland	15-704
117	Podlaskie Centrum Psychogeriatrii	Białystok	Podlaskie	Poland	15-756
118	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk	Pomorskie	Poland	80-546
119	Solumed Centrum Medyczne	Poznan	Wielkopolskie	Poland	60-529
120	Nzoz Neuro-Kard Ilkowski i Partnerzy SPL	Poznan	Wielkopolskie	Poland	61-853
121	NZOZ Centrum Medyczne HCP	Poznań	Wielkopolskie	Poland	61-485
122	Centrum Medyczne Euromedis	Szczecin	Zachodniopomorskie	Poland	70-111
123	IRMED Osrodek Badan Klinicznych	Piotrkow Trybunalski	Łódzkie	Poland	97-300
124	Klinika Neuro-Care	Siemianowice Slaskie	Śląskie	Poland	41-100
125	IBISMED Wielospecjalistyczne Centrum Medyczne	Zabrze	Śląskie	Poland	41-800
126	Clinhouse Centrum Medyczne	Zabrze	Śląskie	Poland	41-807
127	Hospital Victoria Eugenia	Seville	Andalucía	Spain	41009
128	Fundació ACE	Barcelona	Barcelona [Barcelona]	Spain	08028
129	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]	Spain	08035
130	Hospital Universitari General de Catalunya	Sant Cugat del Vallès	Barcelona [Barcelona]	Spain	08915
131	Hospital Clínic de Barcelona	Barcelona	Catalunya [Cataluña]	Spain	08036
132	Hospital Universitari de Santa Maria	Lleida	Lleida [Lérida]	Spain	25198
133	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcon	Madrid	Spain	28223
134	Policlinica Gipuzkoa	San Sebastián	País Vasco	Spain	20014
135	Hospital Universitario Doctor Peset	Valencia	Valenciana, Comunitat	Spain	46017
136	Hospital La Princesa	Madrid		Spain	28006
137	Hospital Universitari i Politecnic La Fe	València		Spain	46026
138	Chang Gung Memorial Hospital at Kaohsiung	Kaohsiung Niao-Sung Dist	Kaohsiung	Taiwan	83301
139	Cardinal Tien Hospital	New Taipei City	New Taipei	Taiwan	231
140	Taipei Veterans General Hospital	Taipei City	Taipei	Taiwan	112
141	Tri-Service General Hospital	Taipei City	Taipei	Taiwan	114
142	National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region	Douliu City	Yunlin	Taiwan	640
143	Taipei Medical University Shuang Ho Hospital	New Taipei		Taiwan	235
144	China Medical University Hospital	Taichung		Taiwan	404332
145	National Cheng-Kung Uni. Hosp.	Tainan		Taiwan	704
146	National Taiwan University Hospital	Taipei		Taiwan	10002
147	Chang Gung Memorial Hospital-Taipei	Taipei		Taiwan	105
148	Chang Gung Medical Foundation-Linkou Branch	Taoyuan		Taiwan	333

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company